Improvement of quality of life

Patients receiving ELOCTA individualised prophylaxis in A-LONG reported a significant improvement in QoL at Week 28 after switching from standard half-life rFVIII: –3.2 total score (P=0.0336)*,2

Improvements in Haem-A-QoL were maintained over 24 months of follow-up in the ASPIRE extension trial: –3.2 total score (P≤0.01)*,1

Data

Adapted from Su et al. ISTH 2017 Poster PB-1783.1

ELOCTA significantly improved QoL total health scores over 24 months' follow-up in adult subjects vs. A-LONG baseline‡,1

Haem-A-QoL, Haemophilia Quality of Life Questionnaire for Adults; QoL, quality of life; rFVIII, recombinant Factor VIII.

*Reduction from baseline in Haem-A-QoL (post hoc exploratory analyses).1,2

p≤0.01; error bars stand for standard error of the mean.

As of third ASPIRE interim data cut (11 January 2016).

n = the number of observations at ASPIRE month 24.

References

1. Su J, Tsao E, Feng J, Myren KJ, Glazebrook D. Long-Term Quality-of-Life Outcomes with rFVIIIFc Prophylaxis in Adult Subjects with Severe Hemophilia A. Poster presented at the XXVI International Society on Thrombosis and Haemostasis (ISTH) Congress; 2017 Jul 8─13; Berlin, Germany. PB1783.

2. Wyrwich KW, Krishnan S, Auguste P, Poon JL, von Maltzahn R, Yu R, et al. Changes in health-related quality of life with treatment of longer-acting clotting factors: results in the A-LONG and B-LONG clinical studies. Haemophilia 2016 Nov;22(6):866-72.

87% of A-LONG/Kids A-LONG subjects reported more or the same amount of physical activity over the course of the studies while maintaining or lowering ABRs*,1
Data

Adapted from Quon et al. Haemophilia 2017.1

  • Changes in physical activity were noted across all age groups1
  • Physical activity can improve joint, bone and muscle health in people with haemophilia2

ELOCTA® supports physical activity, a core part of an active life without restrictions1

*Supplemental rFVIII dosing prior to physical activity was not permitted during the study.1

rFVIII, recombinant Factor VIII.

References

1. Quon DV, Klamroth R, Kulkarni R, Shapiro AD, Baker RI, Castaman G, et al. Low bleeding rates with increase or maintenance of physical activity in patients treated with recombinant factor VIII Fc fusion protein (rFVIIIFc) in the A-LONG and Kids A-LONG studies. Haemophilia. 2017 Jan;23(1):e39–e42.

2. Niu X, Poon JL, Riske B, Zhou ZY, Ullman M, Lou M, et al. Physical activity and health outcomes in persons with haemophilia B. Haemophilia. 2014 Nov;20(6):814–21.

ELOCTA® may allow up to a 50% reduction in annual injections*,1

 

99% of patients needed fewer injections vs standard half-life rFVIII (post-hoc analysis of A-LONG; n=79/80)†,‡,§,1

  • Most patients could reduce to one injection per week compared to previous SHL FVIII regimens and were injecting ELOCTA twice weekly, 30% of patients achieved a dosing interval of 5 days1

ELOCTA can offer a lower burden treatment schedule compared to previous therapy to help liberate the lives of PwH1

PwH, people with haemophilia; rFVIII, recombinant Factor VIII.

*15/65 patients went from 3 injections/week to 1.4 injections/week (a 53% reduction).1
All subjects in the individualised prophylaxis arm of the A-LONG study started on a twice-weekly prophylactic regimen (25 IU/kg on day 1 and 50 IU/kg on day 4; total weekly dose, 75 IU/kg per week), with subsequent dose and interval adjustments based on individual pharmacokinetic information and bleeding.1
One subject reported a pre-study FVIII regimen of 12 IU/kg twice weekly, began the study on the initial twice-weekly ELOCTA regimen, and ended the study on a regimen of 30 IU/kg every 3 days; VWF: Ag level at baseline was 160; pre-study bleeding rate was 42.0; overall on-study ABR was 7.5; ABR in the last 3 months on-study was 0.0.1
§Among patients in the study ≥6 months.1

Reference

1. Shapiro AD, Ragni MV, Kulkarni R, Oldenberg J, Srivastava A, Quon DV, et al. Recombinant factor VIII Fc fusion protein: extended-interval dosing maintains low bleeding rates and correlates with von Willebrand factor levels. J Thromb Haemost. 2014 Nov;12(11):1788–800.

Improvement of quality of life

Patients receiving ELOCTA individualised prophylaxis in A-LONG reported a significant improvement in QoL at Week 28 after switching from standard half-life rFVIII: –3.2 total score (P=0.0336)*,2

Improvements in Haem-A-QoL were maintained over 24 months of follow-up in the ASPIRE extension trial: –3.2 total score (P≤0.01)*,1

Data

Adapted from Su et al. ISTH 2017 Poster PB-1783.1

ELOCTA significantly improved QoL total health scores over 24 months' follow-up in adult subjects vs. A-LONG baseline‡,1

Haem-A-QoL, Haemophilia Quality of Life Questionnaire for Adults; QoL, quality of life; rFVIII, recombinant Factor VIII.

*Reduction from baseline in Haem-A-QoL (post hoc exploratory analyses).1,2

p≤0.01; error bars stand for standard error of the mean.

As of third ASPIRE interim data cut (11 January 2016).

n = the number of observations at ASPIRE month 24.

References

1. Su J, Tsao E, Feng J, Myren KJ, Glazebrook D. Long-Term Quality-of-Life Outcomes with rFVIIIFc Prophylaxis in Adult Subjects with Severe Hemophilia A. Poster presented at the XXVI International Society on Thrombosis and Haemostasis (ISTH) Congress; 2017 Jul 8─13; Berlin, Germany. PB1783.

2. Wyrwich KW, Krishnan S, Auguste P, Poon JL, von Maltzahn R, Yu R, et al. Changes in health-related quality of life with treatment of longer-acting clotting factors: results in the A-LONG and B-LONG clinical studies. Haemophilia 2016 Nov;22(6):866-72.

87% of A-LONG/Kids A-LONG subjects reported more or the same amount of physical activity over the course of the studies while maintaining or lowering ABRs*,1
Data

Adapted from Quon et al. Haemophilia 2017.1

  • Changes in physical activity were noted across all age groups1
  • Physical activity can improve joint, bone and muscle health in people with haemophilia2

ELOCTA® supports physical activity, a core part of an active life without restrictions1

*Supplemental rFVIII dosing prior to physical activity was not permitted during the study.1

rFVIII, recombinant Factor VIII.

References

1. Quon DV, Klamroth R, Kulkarni R, Shapiro AD, Baker RI, Castaman G, et al. Low bleeding rates with increase or maintenance of physical activity in patients treated with recombinant factor VIII Fc fusion protein (rFVIIIFc) in the A-LONG and Kids A-LONG studies. Haemophilia. 2017 Jan;23(1):e39–e42.

2. Niu X, Poon JL, Riske B, Zhou ZY, Ullman M, Lou M, et al. Physical activity and health outcomes in persons with haemophilia B. Haemophilia. 2014 Nov;20(6):814–21.

ELOCTA® may allow up to a 50% reduction in annual injections*,1

 

99% of patients needed fewer injections vs standard half-life rFVIII (post-hoc analysis of A-LONG; n=79/80)†,‡,§,1

  • Most patients could reduce to one injection per week compared to previous SHL FVIII regimens and were injecting ELOCTA twice weekly, 30% of patients achieved a dosing interval of 5 days1

ELOCTA can offer a lower burden treatment schedule compared to previous therapy to help liberate the lives of PwH1

PwH, people with haemophilia; rFVIII, recombinant Factor VIII.

*15/65 patients went from 3 injections/week to 1.4 injections/week (a 53% reduction).1
All subjects in the individualised prophylaxis arm of the A-LONG study started on a twice-weekly prophylactic regimen (25 IU/kg on day 1 and 50 IU/kg on day 4; total weekly dose, 75 IU/kg per week), with subsequent dose and interval adjustments based on individual pharmacokinetic information and bleeding.1
One subject reported a pre-study FVIII regimen of 12 IU/kg twice weekly, began the study on the initial twice-weekly ELOCTA regimen, and ended the study on a regimen of 30 IU/kg every 3 days; VWF: Ag level at baseline was 160; pre-study bleeding rate was 42.0; overall on-study ABR was 7.5; ABR in the last 3 months on-study was 0.0.1
§Among patients in the study ≥6 months.1

Reference

1. Shapiro AD, Ragni MV, Kulkarni R, Oldenberg J, Srivastava A, Quon DV, et al. Recombinant factor VIII Fc fusion protein: extended-interval dosing maintains low bleeding rates and correlates with von Willebrand factor levels. J Thromb Haemost. 2014 Nov;12(11):1788–800.